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Mission Tasks and Responsibilities
* Represent the DMPK function in cross-functional teams or in collaboration with external partners to deliver data and support informed decision-making aligned with project goals. Ensure effective communication between the project, the function, and key stakeholders.
* Participate in, oversee, or outsource studies to enhance knowledge of ADME / DMPK in non-clinical and clinical development.
* Manage bioanalytical needs (e.g., PK, ADA, and Nab assays) for non-GLP or GLP ADME / DMPK studies throughout drug development, ensuring compliance with global regulatory standards (e.g., FDA, EMA).
* Integrate bioanalytical and immunogenicity data to interpret PK results.
* Contribute to designing pre-clinical and clinical translational strategies and MIDD approaches in collaboration with non-clinical and clinical teams.
* Ensure PK, PK/PD, dose predictions, and related deliverables adhere to best practices for study design and regulatory submissions.
* Provide high-quality data and presentations internally and to partners, with regular updates on project progress.
* Author comprehensive reports, including support for regulatory documents such as INDs, CTAs, and BLA filings when needed.
* Evaluate external assets for clinical and nonclinical ADME / DMPK, communicating findings and recommendations clearly to stakeholders.
* Maintain current knowledge of scientific literature, regulatory guidance, and best practices.
Education
* MSc / PhD in Pharmacy, Chemistry, Biochemistry, Biology, Biomedicine, or related Life Sciences.
Specific Knowledge
* Broad experience in bioanalytical science for biotherapeutics.
* Expertise in immunogenicity testing and related sciences in preclinical and clinical drug discovery/development.
* Strong understanding of translational medicine, connecting preclinical and clinical DMPK, including modeling & simulation concepts.
* In-depth knowledge of regulatory requirements and guidelines for NBE ADME / DMPK, with the ability to de-risk drug submissions by understanding regulatory expectations.
Experience
At least 7 years of industry experience in ADME / DMPK / Bioanalysis of biological molecules such as NBEs, ADCs, or other novel modalities.
Valued Experience
* Experience with mRNA LNPs modality is highly desirable.
* Strong teamwork and leadership skills.
* Ability to operate in a matrix environment, multitask, meet deadlines, and adapt to changing priorities.
* Strategic thinking with leadership qualities and collaborative skills across disciplines.
* Ability to build and maintain professional networks for collaborative efforts.
* Fluent in both oral and written English for effective communication and documentation.
Values
* Care: We listen, empathize, value diverse perspectives, and support each other's success.
* Courage: We challenge the status quo, take ownership, and learn from successes and failures.
* Innovation: We focus on patients and customers, create novel solutions, and foster entrepreneurial mindsets.
* Simplicity: We act decisively, understand the reasons behind actions, and stay agile and straightforward.
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